The goal of obtaining informed consent is to provide information so that prospective subjects understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. Show
At the bottom of the page is a Sample Informed Consent Form and a Sample Template for an Online Survey Informed Consent Form.Informed consent is one of the primary ethical requirements of research with human subjects. Informed consent is not a single event or just a form to be signed; it is an educational process that takes place between the investigator and the prospective subject. The basic elements of the consent process include:
It is the investigator’s responsibility to document that the informed consent process has taken place, and an informed consent form is the standard for documenting the process for research projects involving human subjects. When the participant population is not homogeneous, different consent documents may be required for different groups of people. If the research population will include participants under 18 years of age, then the IRB will expect investigators to use an assent form and a parental permission form instead. Similarly, research with cognitively or decisionally-impaired individuals will require documented consent from another party—namely that person’s legally authorized representative. The IRB also recognizes that there are instances when documenting written informed consent is not appropriate to a research project. A request should be made to the IRB for a waiver of informed consent with justification in your IRB proposal. Regardless of the method of documenting informed consent, however, the process of obtaining informed consent should always contain the same required components. In seeking informed consent, the following information shall be provided to each subject:
Sample informed consent form:(Title of Research Project) I consent to serve as a participant in the research investigation entitled (title of project) being conducted by (name of researcher/s) as part of (a senior research project/a class project/a research project) for (name of class or department) at Monmouth College. This investigation has been approved by the Monmouth College Institutional Review Board with project number XX-XX (include project number after approval). I understand that this study is investigating (include a brief description of the study topic). As a participant in this study, I will be asked to (describe all of the tasks that participants in the study will complete). This study will last approximately (include a high estimate of how long your study will take). I understand that the potential benefits of this study to participants are (describe the potential benefits of participating in your study here, including any compensation for participation) OR there are no direct benefits or compensation for my participation in this study. The potential risks to participants in this study are not greater than one may encounter in everyday life (OR describe any risks here). I understand that the information that I provide is confidential and my identity will not be revealed (include an explanation of how confidentiality will be ensured and what will be done with the data once the study is completed). I understand that my participation is voluntary and that I am free to withdraw consent and to discontinue participation in the project at any time without penalty. If I have any questions about the project, either before it begins or after I have participated, I may ask the researcher directly (or contact the researcher’s advisor) using the contact information below. I am at least 18 years old. My signature indicates that I have read and understand the information presented above, that I have decided to participate, and that I consent to the procedures or treatment described above. Participant’s Signature: Researcher’s Name: Faculty Advisor’s Name: Sample Template for Online Survey Informed Consent Form:(Title of Research Project) [Include all the standard informed consent document content here and add the following:] I understand that I will complete this study anonymously online. Because information is being transmitted via the internet, complete anonymity cannot be guaranteed; however, all reports based on my responses will combine my data with other participants’ data and will not reveal my identity or my participation in this project. [If participants are students receiving extra course credit for participation, explain how this will be done to maintain confidentiality.] I understand that my participation is voluntary and that I am free to withdraw consent and to discontinue participation in the project at any time without penalty by closing the survey prior to completion. Because this is an online survey, I understand that once I have completed the study and submitted the data, it will not be possible to withdraw my data. If I have questions about the project either before it begins or after I have participated, I may ask the researcher directly, or contact the researcher’s advisor, using the contact information below. I am at least 18 years old. Clicking the “I agree” box and providing my online signature indicates that I have read and understand the information presented above, that I have decided to participate, and that I consent to the procedures described above. ____ I agree to the terms and conditions above. Researcher’s Name: Researcher’s Contact Information: Faculty Advisor’s Name: Faculty Advisor’s Contact Information: Which of the following must be included in the informed consent in research?Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks.
When obtaining informed consent from a participant What must the researcher to quizlet?Terms in this set (38) Obtaining informed consent from research participants is a process that involves: informing the participants about research and obtaining consent to participate in it.
How do you get consent from a research participant?Obtaining consent involves explaining the research and assessing participant comprehension using a consent document, usually a written consent form or information sheet, as a guide for the verbal explanation of the study.
What is informed consent and why do researchers need to obtain it from participants?Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work. A central part of the informed consent process is the informed consent document.
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